Plate with integral fluid path channels

ABSTRACT

A device for delivering medicament into skin of a patient, the device having a housing, which includes a reservoir for housing the medicament, a first internal region that is sealed from fluid ingress and includes one or more components, and a second internal region that is not sealed from fluid ingress and includes one or more components. The housing also has a barrier that separates the first internal region and the second internal region, a delivery cannula that delivers the medicament into the skin of the patient, and a base including a bottom surface for orienting toward the skin of the patient. The bottom surface of the base has one or more fluid channels disposed therein and at least one of the fluid channels is in fluid communication with the delivery cannula.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application Ser. No. 62/053,674, filed on Sep. 22,2014. This application is hereby incorporated by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to medical devices, and more particularly,to medical devices with fluid channels to deliver medicament to apatient.

BACKGROUND OF THE INVENTION

Diabetes is a group of diseases characterized by high levels of bloodglucose resulting from the inability of diabetic patients to maintainproper levels of insulin production when required. Diabetes can bedangerous to the affected patient if it is not treated, and it can leadto serious health complications and premature death. However, suchcomplications can be minimized by utilizing one or more treatmentoptions to help control the diabetes and reduce the risk ofcomplications.

The treatment options for diabetic patients include specialized diets,oral medications and/or insulin therapy. The main goal of diabetestreatment is to control the diabetic patient's blood glucose or sugarlevel. However, maintaining proper diabetes management may becomplicated because it has to be balanced with the activities of thediabetic patient. Type 1 diabetes (T1D) patients are required to takeinsulin (e.g., via injections or infusion) to move glucose from thebloodstream because their bodies generally cannot produce insulin. Type2 diabetes (T2D) patients generally can produce insulin but their bodiescannot use the insulin properly to maintain blood glucose levels withinmedically acceptable ranges. In contrast to people with T1D, themajority of those with T2D usually do not require daily doses of insulinto survive. Many people are able to manage their condition through ahealthy diet and increased physical activity or oral medication.However, if they are unable to regulate their blood glucose levels, theywill be prescribed insulin. For example, there are an estimated 6.2million Type 2 diabetes patients (e.g., in the United States, WesternEurope and Canada) taking multiple-daily-injections (MDI) which consistof a 24-hour basal insulin and a short acting rapid insulin that istaken at mealtimes for glycemic management control.

For the treatment of Type 1 diabetes (T1D) and sometimes Type 2 diabetes(T2D), there are two principal methods of daily insulin therapy. In thefirst method, diabetic patients use syringes or insulin pens toself-inject insulin when needed. This method requires a needle stick foreach injection, and the diabetic patient may require three to fourinjections daily. The syringes and insulin pens that are used to injectinsulin are relatively simple to use and cost effective.

Another effective method for insulin therapy and managing diabetes isinfusion therapy or infusion pump therapy in which an insulin pump isused. The insulin pump can provide continuous infusion of insulin to adiabetic patient at varying rates to more closely match the functionsand behavior of a properly operating pancreas of a non-diabetic personthat produces the required insulin, and the insulin pump can help thediabetic patient maintain his/her blood glucose level within targetranges based on the diabetic patient's individual needs. Infusion pumptherapy requires an infusion cannula, typically in the form of aninfusion needle or a flexible catheter, that pierces the diabeticpatient's skin and through which infusion of insulin takes place.Infusion pump therapy offers the advantages of continuous infusion ofinsulin, precision dosing, and programmable delivery schedules.

In infusion therapy, insulin doses are typically administered at a basalrate and in a bolus dose. When insulin is administered at a basal rate,insulin is delivered continuously over 24 hours to maintain the diabeticpatient's blood glucose levels in a consistent range between meals andrest, typically at nighttime. Insulin pumps may also be capable ofprogramming the basal rate of insulin to vary according to the differenttimes of the day and night. In contrast, a bolus dose is typicallyadministered when a diabetic patient consumes a meal, and generallyprovides a single additional insulin injection to balance the consumedcarbohydrates. Insulin pumps may be configured to enable the diabeticpatient to program the volume of the bolus dose in accordance with thesize or type of the meal that is consumed by the diabetic patient. Inaddition, insulin pumps may also be configured to enable the diabeticpatient to infuse a correctional or supplemental bolus dose of insulinto compensate for a low blood glucose level at the time when thediabetic patient is calculating the bolus dose for a particular mealthat is to be consumed.

Insulin pumps advantageously deliver insulin over time rather than insingle injections, typically resulting in less variation within theblood glucose range that is recommended. In addition, insulin pumps mayreduce the number of needle sticks which the diabetic patient mustendure, and improve diabetes management to enhance the diabeticpatient's quality of life. For example, many of the T2D patients who areprescribed insulin therapy can be expected to convert from injections toinfusion therapy due to an unmet clinical need for improved control.That is, a significant number of the T2D patients who takemultiple-daily-injections (MDI) are not achieving target glucose controlor not adhering sufficiently to their prescribed insulin therapy.

Typically, regardless of whether a diabetic patient uses multiple directinjections (MDIs) or a pump, the diabetic patient takes fasting bloodglucose medication (FBGM) upon awakening from sleep, and also tests forglucose in the blood during or after each meal to determine whether acorrection dose is required. In addition, the diabetic patient may testfor glucose in the blood prior to sleeping to determine whether acorrection dose is required, for instance, after eating a snack beforesleeping.

To facilitate infusion therapy, there are generally two types of insulinpumps, namely, conventional pumps and patch pumps. Conventional pumpsuse a disposable component, typically referred to as an infusion set,tubing set or pump set, which conveys the insulin from a reservoirwithin the pump into the skin of the user. The infusion set includes apump connector, a length of tubing, and a hub or base from which acannula, in the form of a hollow metal infusion needle or flexibleplastic catheter, extends. The base typically has an adhesive thatretains the base on the skin surface during use. The cannula can beinserted onto the skin manually or with the aid of a manual or automaticinsertion device. The insertion device may be a separate unit employedby the user.

Another type of insulin pump is a patch pump. Unlike a conventionalinfusion pump and infusion set combination, a patch pump is anintegrated device that combines most or all of the fluidic components ina single housing. Generally, the housing is adhesively attached to aninfusion site on the patient's skin, and does not require the use of aseparate infusion or tubing set. A patch pump containing insulin adheresto the skin and delivers the insulin over a period of time via anintegrated subcutaneous cannula. Some patch pumps may wirelesslycommunicate with a separate controller device (as in one device sold byInsulet Corporation under the brand name OmniPod®), while others arecompletely self-contained. Such patch pumps are replaced on a frequentbasis, such as every three days, or when the insulin reservoir isexhausted. Otherwise, complications may occur, such as restriction inthe cannula or the infusion site.

As patch pumps are designed to be a self-contained unit that is worn bythe patient, preferably, the patch pump is small, so that it does notinterfere with the activities of the user. Thus, to minimize discomfortto the user, it would be preferable to minimize the overall thickness ofthe patch pump. However, to minimize the thickness of the patch pump,the size of its constituent parts should be reduced as much as possible.

In current patch pump designs, tubes, such as plastic tubes, areemployed as fluid pathways to route fluid flow from one internalcomponent to another. For example, a tube can connect a medicamentreservoir with a delivery needle, but the space required to internallyhouse such a tube adds to the overall size of the patch pump. The use oftubes can increase cost and can result in additional complexity duringautomated device assembly processes. For example, such device assemblyincludes connecting the tubes, which adds steps to the assembly process.In addition, preventing leaks from such connections can give rise toadditional challenges.

Accordingly, a need exists for an improved fluid path design for use ina limited space environment, such as in a patch pump device, which cancost-effectively transport medicament, while minimizing or reducing theoverall size and complexity of the device.

SUMMARY OF EMBODIMENTS OF THE INVENTION

It is an aspect of the present invention to provide a patch pump inwhich one or more fluid channels bypass a fluid ingress barrier toeffectively and efficiently administer the medicament to the patient.Sensors and fluid channels provide a bypass from a wet interface to adry interface with minimal complexity by routing flow away from thespecific interface.

The foregoing and/or other aspects of the present invention can beachieved by providing a device for delivering medicament into skin of apatient, the device having a housing, which includes a reservoir forhousing the medicament, a first internal region that is sealed fromfluid ingress and includes one or more components, and a second internalregion that is not sealed from fluid ingress and includes one or morecomponents. The housing also has a barrier that separates the firstinternal region and the second internal region, a delivery cannula thatdelivers the medicament into the skin of the patient, and a baseincluding a bottom surface for orienting toward the skin of the patient.The bottom surface of the base has one or more fluid channels disposedtherein and at least one of the fluid channels is in fluid communicationwith the delivery cannula.

The foregoing and/or other aspects of the present invention can also beachieved by providing a medicament delivery device including a housinghaving an interior, the housing having a fluid channel disposed therein.The fluid channel passes from a first position in the interior, to asecond position outside the housing, and to a third position in theinterior.

The foregoing and/or other aspects of the present invention can befurther achieved by providing a medicament delivery method includingdisposing medicament in an interior of a housing and transporting themedicament in a fluid channel traveling from the interior of the housingto outside of the housing, and back into the interior of the housing.

Moreover, the foregoing and/or other aspects of the present inventioncan be achieved by providing a medicament delivery device including ahousing having an interior, the housing including a reservoir forhousing medicament, a fill port in fluid communication with thereservoir, a delivery mechanism that delivers the medicament into skinof a patient, a pump that controls flow of the medicament to thedelivery mechanism, and a base having first and second fluid channelsdisposed therein. The pump is in fluid communication with the deliverymechanism via the first fluid channel and one of the fluid channels isdisposed, at least in part, outside the interior of the housing.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.The present invention may comprise delivery devices and methods forforming and operating same having one or more of the above aspects,and/or one or more of the features and combinations thereof. The presentinvention may comprise one or more of the features and/or combinationsof the above aspects as recited, for example, in the attached claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and/or other aspects and advantages of embodiments of theinvention will be more readily appreciated from the following detaileddescription, taken in conjunction with the accompanying drawings, ofwhich:

FIG. 1 is a perspective view of a patch pump constructed in accordancewith an illustrative embodiment of the present invention;

FIG. 2 is an exploded view of the various components of the patch pumpof FIG. 1, illustrated with a cover;

FIG. 3 is a perspective view of an alternative design for a patch pumphaving a flexible reservoir, illustrated without a cover, in accordancewith an illustrative embodiment of the present invention;

FIG. 4 is a perspective view of a patch-pump fluidic architecture andmetering sub-system diagram of the patch pump of FIG. 3;

FIG. 5 illustrates an example wireless remote controller for controllingthe operation of a medicine delivery device such as, for example, apatch pump, in accordance with an illustrative embodiment of the presentinvention;

FIG. 6 is a perspective view of a patch pump in accordance with anillustrative embodiment of the present invention;

FIG. 7 is a cross-sectional view of FIG. 6 taken along line 7-7 of FIG.6;

FIG. 8 is a perspective view of the patch pump of FIG. 6, omitting acover and a reservoir;

FIG. 9 is a bottom view of the patch pump of FIG. 6;

FIG. 10 is a partial cross-sectional view of the patch pump of FIG. 6taken along line 10-10 of FIG. 9;

FIG. 11 is a perspective view of a plate in accordance with anembodiment of the present invention;

FIG. 12 is a perspective view of a patch pump incorporating the plate ofFIG. 11;

FIGS. 13-15 are perspective views of a flow channel member in accordancewith an embodiment of the present invention; and

FIG. 16 is a schematic illustration of a medicament flow path of a patchpump in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Reference will now be made in detail to embodiments of the presentinvention, which are illustrated in the accompanying drawings, whereinlike reference numerals refer to like elements throughout. Theembodiments described herein exemplify, but do not limit, the presentinvention by referring to the drawings.

It will be understood by one skilled in the art that this disclosure isnot limited in its application to the details of construction and thearrangement of components set forth in the following description orillustrated in the drawings. The embodiments herein are capable of otherembodiments, and capable of being practiced or carried out in variousways. Also, it will be understood that the phraseology and terminologyused herein is for the purpose of description and should not be regardedas limiting. The use of “including,” “comprising,” or “having” andvariations thereof herein is meant to encompass the items listedthereafter and equivalents thereof as well as additional items. Unlesslimited otherwise, the terms “connected,” “coupled,” and “mounted,” andvariations thereof herein are used broadly and encompass direct andindirect connections, couplings, and mountings. In addition, the terms“connected” and “coupled” and variations thereof are not restricted tophysical or mechanical connections or couplings. Further, terms such asup, down, bottom, and top are relative, and are employed to aidillustration, but are not limiting.

The illustrative embodiments are described with reference to diabetesmanagement using insulin therapy. It is to be understood that theseillustrative embodiments can be used with different drug therapies andregimens to treat other physiological conditions than diabetes usingdifferent medicaments than insulin.

FIG. 1 is a perspective view of an exemplary embodiment of a medicinedelivery device comprising a patch pump 1 according to an exemplaryembodiment of the invention. The patch pump 1 is illustrated with asee-through cover for clarity and illustrates various components thatare assembled to form the patch pump 1. FIG. 2 is an exploded view ofthe various components of the patch pump of FIG. 1, illustrated with amain cover 2. The various components of the patch pump 1 may include: areservoir 4 for storing insulin; a pump 3 for pumping insulin out of thereservoir 4; a power source 5 in the form of one or more batteries; aninsertion mechanism 7 for inserting an inserter needle with a catheterinto a user's skin; control electronics 8 in the form of a circuit boardwith optional communications capabilities to outside devices such as aremote controller and computer, including a smart phone; a pair of dosebuttons 6 on the cover 2 for actuating an insulin dose, including abolus dose; and a base 9 to which various components above may beattached via fasteners 91. The patch pump 1 also includes various fluidconnector lines that transfer insulin pumped out of the reservoir 4 tothe infusion site.

FIG. 3 is a perspective view of an alternative design for a patch pump1A having a flexible reservoir 4A, and illustrated without a cover. Sucharrangement may further reduce the external dimensions of the patch pump1A, with the flexible reservoir 4A filling voids within the patch pump1A. The patch pump 1A is illustrated with a conventional cannulainsertion device 7A that inserts the cannula, typically at an acuteangle, less than 90 degrees, at the surface of a user's skin. The patchpump 1A further comprises: a power source 5A in the form of batteries; ametering sub-system 41 that monitors the volume of insulin and includesa low volume detecting ability; control electronics 8A for controllingthe components of the device; and a reservoir fill port 43 for receivinga refill syringe 45 to fill the reservoir 4A.

FIG. 4 is a patch-pump fluidic architecture and metering sub-systemdiagram of the patch pump 1A of FIG. 3. The power storage sub-system forthe patch pump 1A includes batteries 5A. The control electronics 8A ofthe patch pump 1A may include a microcontroller 81, sensing electronics82, pump and valve controller 83, sensing electronics 85, and deploymentelectronics 87, which control the actuation of the patch pump 1A. Thepatch pump 1A includes a fluidics sub-system that may include areservoir 4A, volume sensor 48 for the reservoir 4A, a reservoir fillport 43 for receiving a refill syringe 45 to refill the reservoir 4A.The fluidics sub-system may include a metering system comprising a pumpand valve actuator 411 and an integrated pump and valve mechanism 413.The fluidics sub-system may further include an occlusion sensor, adeploy actuator, as well as the cannula 47 for insertion into aninfusion site on the user's skin. The architecture for the patch pumpsof FIGS. 1 and 2 is the same or similar to that which is illustrated inFIG. 4.

With reference to FIG. 5, the wearable medical delivery device (e.g.,insulin delivery device (IDD) such as patch pump 1 is operable inconjunction with a remote controller that preferably communicateswirelessly with the pump 1 and is hereinafter referred to as thewireless controller (WC) 500. The WC can comprise a graphical userinterface (GUI) display 502 for providing a user visual informationabout the operation of the patch pump 1 such as, for example,configuration settings, an indication when a wireless connection to thepatch pump is successful, and a visual indication when a dose is beingdelivered, among other display operations. The GUI display 502 caninclude a touchscreen display that is programmed to allow a user toprovide touch inputs such as a swipe to unlock, swipe to confirm arequest to deliver a bolus, and selection of confirmation or settingsbuttons, among other user interface operations.

The WC 500 can communicate with the delivery device (e.g., patch pump 1)using any one or more of a number of communication interfaces 504. Forexample, a near field radiation interface is provided to synchronize thetiming of the WC and patch pump 1 to facilitate pairing upon start up.Another interface can be provided for wireless communication between theWC and the patch pump 1 that employs a standard BlueTooth Low Energy(BLE) layer, as well as Transport and Application layers. Non-limitingexamples of Application layer commands include priming, delivering basaldose, delivering bolus dose, cancelling insulin delivery, checking patchpump 1 status, deactivating the patch pump 1, and patch pump 1 status orinformation reply.

FIG. 6 is a perspective view of a patch pump 1 according to an exemplaryembodiment of the present invention. The patch pump 1 has a housing 10,which includes a main cover 2 liquid sealed or, preferably, hermeticallysealed to a base 9. The base 9 carries various components as describedbelow in detail. The hermetic seal prevents fluid ingress and preventsother particles from passing the seal. Embodiments of the patch pump 1also include a vent or a vent membrane along with a sealing methoddescribed herein to provide pressure equalization.

Embodiments of the seal include, for example, a liquid-tight seal, anO-ring seal or another mechanical seal, a gasket, an elastomer, a heatseal, an ultra-sonically welded seal, a laser weld, chemical joining, anadhesive, a solvent weld, or an adhesive weld. Laser welding is thepreferred sealing method because, when laser welding is properlyperformed, a seamless fully hermetic seal is formed. The vent or thevent membrane continues to have the functional purpose of equalizinginternal pressure and providing a sterile environment. One skilled inthe art will appreciate that other seals can be used without departingfrom the scope of the present invention.

FIG. 7 is a cross-sectional view of the patch pump 1 illustratingvarious components. The main cover 2 and the base 9 define an interior12 divided by a barrier 20 into a first internal region 14 and a secondinternal region 16. According to one embodiment, the patch pump 1preferably includes a reservoir 4 for storing medicament (such asinsulin), a pump 3 for pumping the medicament to exit the reservoir 4,and a force sensing resistor 30 for detecting an amount of pressure in amedicament flow path. The patch pump 1 also preferably includeselectronics 8 for programming and operating the patch pump 1, and aninsertion mechanism 7 for inserting a cannula 47 into a skin of thepatient to deliver medicament.

As previously noted, the interior 12 of the patch pump 1 is divided bythe barrier 20 into the first internal region 14 and the second internalregion 16. According to one embodiment, the barrier 20 is a part of themain cover 2. Preferably, the barrier 20 is integrally formed as aunitary structure with the main cover 2. The barrier 20 is preferablysealed to a protrusion 18 on the base 9 such that the interface betweenthe barrier 20 and the protrusion 18 is hermetically joined using any ofthe processing methods described above or any other appropriateconventional sealing method. Alternatively, the interface between thebarrier 20 and the protrusion 18 can be liquid sealed. The barrier 20separates the first internal region 14 from the second internal region16 and protects the first internal region 14 from fluid ingress.According to one embodiment, the second internal region 16 is not sealedfrom fluid ingress.

The first internal region 14 includes components such as the pump 3, theforce sensing resistor 30, and the electronics 8. Examples of theelectronics 8 include semiconductor chips, controllers, diodes,antennas, coils, batteries, discrete components (resistors andcapacitors, for example) and circuit boards used to operate and controlthe patch pump 1 and operate the pump 1 in conjunction with the WC 500.As readily understood by the skilled artisan, it is desirable to have adry environment for proper operation of these components, particularlythe electronics 8. The second internal region 16 includes the insertionmechanism 7 and the cannula 47. According to one embodiment, because theinsertion mechanism 7 interfaces with the skin of a patient, the secondinternal region 16 is neither a hermetically sealed environment, nor aliquid-tight environment.

According to one embodiment, the components of the first internal region14 are different from the components of the second internal region 16.Alternatively, the first internal region 14 and the second internalregion 16 share some of the same components. For example, in someembodiments, portions of the reservoir 4 are disposed in both the firstand second internal regions 14, 16. When the reservoir and the insertionmechanism 7 are separated by the barrier 20, however, the two internalregions 14, 16 fluidly communicate for effective operation of the patchpump 1.

FIG. 8 illustrates some of the main components of the patch pump 1 in aperspective view with the main cover 2 and the reservoir 4 removed forclarity. According to one embodiment, a fill port 43 is a conduit forsupplying the medicament to the reservoir 4. The fill port 43 can bedisposed in the first internal region 14 or the second internal region16, but is preferably located in the first internal region 14. In someembodiments, the fill port 43 includes a portion that serves as part ofthe flow path for medicament exiting the reservoir 4.

Preferably, a receptacle 32 is connected to the insertion mechanism 7 bytubing, for example, to transfer the medicament to the insertionmechanism 7 prior to injection into the skin of the patient. Accordingto one embodiment, the receptacle 32 is disposed in the second internalregion 16.

FIG. 9 illustrates a bottom surface 22 of the base 9 of the patch pump1. During use, the bottom surface 22 is oriented toward the skin of thepatient. In some embodiments, the bottom surface 22 can include adhesivethat removably attaches the base 9 to the skin of the patient.Alternatively, an adhesive pad 70, as illustrated in FIG. 6, adheres toboth the bottom surface 22 and the skin of the patient. Preferably, 3M™medical tape (e.g. product no. 1776) is the adhesive used, althoughvarious types of known industry adhesives can be used. However, theadhesive is carefully selected to ensure compatibility with human skinto prevent undesired reactions. Also, compatibility of the adhesive andthe insulin is considered in case that the adhesive and the insulinaccidentally mix. The adhesive or adhesive pad are also placed over afluid channel cover 28 covering first and second fluid channels 24, 26which are described in detail below.

As shown in FIG. 9, the bottom surface 22 of the base 9 includes firstand second fluid channels 24, 26. The first and second fluid channels24, 26 provide fluid pathways between various components in the patchpump 1. According to one embodiment, the first and second fluid channels24, 26 advantageously establish fluid communication between variouscomponents such as the reservoir 4, the fill port 43, the force sensingresistor 30, the pump 3, and the insertion mechanism 7.

Preferably, the first and second fluid channels 24, 26 are recessed from(or inscribed into) the bottom surface 22, and are formed through amolding process, such as injection molding, or by a cutting process,such as milling. In other embodiments, the first and second fluidchannels 24, 26 are disposed on the main cover 2, or on the base 9within the interior 12 of the patch pump 1. Similar fluid channels canbe positioned in a plurality of locations in embodiments of the device.

The cross-sectional shape of the first and second fluid channels 24, 26is defined based on desired flow characteristics. The geometry of thefirst and second flow channels 24, 26 is selected based on factors suchas cost, manufacturing capability, and desired use. Exemplarycross-sectional profiles of the first and second fluid channels 24, 26include square, rectangular, and semi-circular. One skilled in the artwill appreciate that other cross-sectional profiles can be employedwithout departing from the scope of the present invention.

Preferably, the first and second fluid channels 24, 26 are sized toallow unrestricted medicament fluid flow. In other words, the pump 3connected to the first and second fluid channels 24, 26 controls anddetermines the medicament fluid flow rate, instead of the size of thefirst and second fluid channels 24, 26. Specifically, if the first andsecond fluid channels 24, 26 are too small, capillary action can occur,potentially resulting in the obstruction of medicament fluid flow.Preferably, the cross-sectional area of the first and second fluidchannels 24, 26 is greater than the gage of the cannula 47.

According to one embodiment as illustrated in FIG. 9, the first andsecond fluid channels 24, 26 are encapsulated by a fluid channel cover28 which is illustrated as being transparent for clarity. But oneskilled in the art will appreciate that the opacity of the fluid channelcover 28 or other portions of the device can vary without departing fromthe scope of the present invention. The fluid channel cover 28 is, forexample, clear film, foil, a flexible sheet/film or a semi-rigid/rigidpart made of any suitable material.

According on one embodiment, the film channel cover 28 is made of foilavailable from Oliver-Tolas Healthcare Packaging (e.g., TPC-0777A foil).Preferably, the film channel cover 28 is made of Oliver-Tolas HealthcarePackaging IDT-6187 clear film and is heat sealed or heat staked to thebottom surface 22 of the base 9 to embed the first and second fluidchannels 24, 26. Laser welding, for example, applies laser light throughthe clear film to fix the film channel cover 28 to the bottom surface 22of the base 9. Laser welding is advantageous because a laser canstraddle the channel edge of the fluid channels 24, 26 during thewelding process and adhere the film to the base 9 in areas that arecloser to the channel edges than other methods.

The fluid channel cover 28 is sealed to the base 9 via any of theprocessing methods described above. Accordingly, it is desirable for thematerial of the fluid channel cover 28 to be compatible with thematerial of the base 9 for the purposes of effective processing,joining, liquid sealing, and hermetic sealing. In addition, because themedicament comes into contact with the fluid channel cover 28, care istaken in the selection of the fluid channel cover 28 to ensurecompatibility with the medicament.

The sealed fluid channel cover 28 encloses and protects the medicamentfrom any contamination while travelling through the first and secondfluid channels 24, 26. According to one embodiment, a single fluidchannel cover 28 encapsulates each of the first and second fluidchannels 24, 26. Alternatively, a separate fluid channel cover 28 canencapsulate each of the first and second fluid channels 24, 26. Becausefluid channels can also be disposed in the interior 12 of the patch pump1 as described above, one or more fluid channel covers 28 can beappropriately disposed in the interior 12 of the patch pump 1 as well.

FIG. 10 is a partial cross-sectional view of the patch pump 1 of FIG. 6.According to one embodiment, the base 9 includes a fluid channelpassageway 27, such as a through hole 27, which extends through the base9. As shown in FIG. 10, the fluid channel passageway 27 advantageouslyconnects the receptacle 32 to a first end of the first fluid channel 24.According to one embodiment, a fluid channel passageway 27 is similarlypresent at each end of the first and second fluid channels 24, 26 (seeFIG. 9). Preferably, the fluid channel passageway 27 disposed in thebase 9 at a second end of the first fluid channel 24 connects directlyto the pump 3 disposed in the first internal region 14. Similarly, in apreferred embodiment, opposing ends of the second fluid channel 26connect the reservoir fill port 43 and the pump 3 via the fluid channelpassageways 27.

According to one embodiment, the medicament exits the first internalregion 14 of the patch pump 1 via the passageway 27 in the base 9,entering the first fluid channel 24 in the bottom surface 22 outside ofthe interior 12 of the patch pump 1. Subsequently, via the fluid channelpassageway 27 disposed at the first end of the first fluid channel 24,the medicament reenters the interior 12 of the patch pump 1 into thesecond internal region 16. By routing the medicament through the firstfluid channel 24 outside the interior 12 of the patch pump 1, the firstfluid channel 24 advantageously and effectively bypasses the barrier 20.Therefore, the first fluid channel establishes fluid communicationbetween the pump 3 and the cannula 47 while bypassing the barrier 20,thereby maintaining the barrier 20 integrity. Thus, the first fluidchannel 24 advantageously provides fluid communication between the firstinternal region 14, which is sealed from fluid ingress, and the secondinternal region 16, which is not sealed from fluid ingress withoutcompromising the integrity of the bather 20.

The configuration of the first and second fluid channels 24, 26 in thepatch pump 1 provides a plurality of exemplary benefits. Because thefirst and second fluid channels 24, 26 are integral to the base 9, theyare conveniently manufactured through molding and/or milling, therebypotentially reducing manufacturing costs. Additionally, the barrier 20provides an effective seal between the first and second internal regions14, 16 because the first and second fluid channels 24, 26 bypass thebarrier 20 instead of penetrating the barrier 20. Such a sealingconfiguration advantageously ensures that the critical components in thefirst internal region 14 do not fail due to fluid ingress. The criticalcomponents are disposed in preferred locations, which provides foroptimal component arrangement. Thus, the use of first and second fluidchannels 24, 26 outside of the interior 12 of the patch pump 1 providesconfigurational freedom to designers, aids optimization of the interiorspace, and aids reduction of the overall size of the patch pump 1.

In an alternate embodiment, as illustrated in FIGS. 11 and 12, a flowchannel plate 34 is disposed in the interior 12 of the patch pump 1 toprovide a medicament fluid pathway. The flow channel plate 34 includesfirst and second plate fluid channels 36, 38, encapsulated by a fluidchannel cover 28, which is omitted for clarity. The plate fluid channels36, 38 route medicament fluid flow to the various components through theinterior 12 of the patch pump 1.

According to one embodiment, the force sensing resistor 30 is integrallyformed into the flow channel plate 34 for in-line pressure sensing ofthe medicament fluid flow path. One embodiment of a flow channel plate34 incorporates a receptacle to replace the fill port 43. Ports,receptacles, or joints can advantageously be included in the flowchannel plate 34 to mate various components via a fluid path. Accordingto one embodiment, the flow channel plate 34 is entirely disposed in thefirst internal region 14.

The medicament flow path in the flow channel plate 34 offers furtherflexibility and space optimization options for the arrangement of thevarious components in the patch pump 1. FIG. 12 illustrates an exemplaryembodiment in which components at various locations in the patch pump 1establish fluid communication via the first and second plate fluidchannels 36, 38 in the flow channel plate 34. According to oneembodiment, the first and second plate fluid channels 36, 38 in the flowchannel plate 34 cooperate with the first and second fluid channels 24,26 in the base 9 to provide fluid communication from the reservoir 4 tothe insertion mechanism 7.

In another alternate embodiment, as illustrated in FIGS. 13-15, a flowchannel member 50 includes a first fluid channel portion 52, a secondfluid channel portion 54, and a third fluid channel portion 56 atdifferent elevations with respect to the fill port 43. The embeddedfirst, second, and third fluid channel portions 52, 54, 56 routemedicament fluid flow in different plane locations, as further describedbelow.

Specifically, a septum (not shown) is pierced to allow medicament toflow from the fill port 43. For example, a user inserts a syringe (notshown) to pierce the septum in the fill port 43 to inject the medicamentinside the flow channel member 50 to a first port 58. The first port 58includes a first passageway and a second passageway. The firstpassageway connects the fill port 43 to the reservoir (not shown) tofill the reservoir 4. The second passageway connects the reservoir tothe first fluid channel portion 52.

Prior to the pumping operation, the flow channel member 50 is in aclosed system with the pump 3 (not shown) being in a closed chamber andconnected at a second port 60. Fluid enters the flow channel member 50and travels to the pump 3 and the reservoir 4 thereby filling each ofthe first, second and third fluid channel portions 52, 54, 56.Subsequently, fluid can enter and fill the reservoir 4. As the reservoir4 is being filled, the flow channel member 50 is primed by driving thefluid through the flow channel member 50 by the pump 3 over severalcycles to remove any air present.

During the pumping operation, medicament is drawn from the reservoir bythe pump 3 (not shown) that is connected at the second port 60 disposedat the other end of the flow channel member 50. When the pump 3generates a suctioning pressure, medicament is pulled from the reservoirinto the first fluid channel portion 52 on a top surface of the flowchannel member 50. The medicament subsequently flows down a junction 62(e.g. a through hole) of the flow channel member 50 and enters into asecond fluid channel portion 54 disposed on a bottom surface of the flowchannel member 50. The second fluid channel portion 54 is in fluidcommunication with the third fluid channel portion 56.

According to one embodiment, a through hole connects the second andthird fluid channel portions 54, 56. According to another embodiment,each of the second and third fluid channel portions 54, 56 is deeperthan one-half the thickness of the flow channel member 50, and adjacentends of the second and third fluid channel portions 54, 56 overlap toestablish fluid communication therebetween. Thus, the medicament flowsfrom the second fluid channel portion 54 to the end of the third fluidchannel portion 56 where a second port 60 connects to the pump 3.

As described above, FIGS. 13 and 14 illustrate the first fluid channelportion 52 and the third fluid channel portion 56 being disposed on atop surface of the flow channel member 50 and FIG. 15 illustrates thesecond fluid channel portion 54 being disposed on a bottom surface ofthe flow channel member 50. In this exemplary embodiment, the flowchannel member 50 has three separate fluid channel covers 28 (notillustrated for clarity) encapsulating each of the first, second, andthird fluid channel portions 52, 54, 56.

The flow channel member 50, or the like, advantageously provides for avariety of different component arrangements in the patch pump 1 toestablish fluid communication through the interior of the patch pump 1.Specifically, the flow channel member 50 advantageously providesdifferent fluid channel portions 52, 54, 56 at different elevations ordifferent planar positions to provide flexibility when interfacing themedicament flow path with the various components in the patch pump 1.The use of the flow channel member 50, or the like, with fluid paths atdifferent elevations also advantageously provides alternate routingcapabilities for space optimization within the pump interior 12.

FIG. 16 is a schematic of an exemplary fluid path in the patch pump 1 inaccordance with an illustrative embodiment of the present invention.Medicament enters the patch pump 1 via the fill port 43 to fill thereservoir 4. During operation of the patch pump 1, the pump 3 pullsmedicament to exit the reservoir 4 into the fill port 43 via anauxiliary port, and subsequently flow to the inlet of the pump 3 via thesecond fluid channel 26. Next, the pump 3 drives the medicament to exitthe pump 3, enter the first fluid channel 24, and flow to the receptacle32 of the insertion mechanism 7. Finally, the insertion mechanism 7receives the medicament from the receptacle 32 via tubing, for example,and delivers the medicament through the cannula 47 to the skin of thepatient.

Although only a few embodiments of the present invention have been shownand described, the present invention is not limited to the describedembodiments. Instead, it will be appreciated by those skilled in the artthat changes may be made to these embodiments without departing from theprinciples and spirit of the invention. It is particularly noted thatthose skilled in the art can readily combine the various technicalaspects of the various elements of the various exemplary embodimentsthat have been described above in numerous other ways, all of which areconsidered to be within the scope of the invention, which is defined bythe appended claims and their equivalents.

What is claimed is:
 1. A device for delivering medicament into skin of apatient, the device comprising: a housing comprising: a reservoir forhousing the medicament; a first internal region that is sealed fromfluid ingress and includes one or more components; a second internalregion that is not sealed from fluid ingress and includes one or morecomponents; a barrier that separates the first internal region and thesecond internal region; a base including a bottom surface for orientingtoward the skin of the patient, the bottom surface of the base havingone or more fluid channels disposed therein; and a delivery cannula thatdelivers the medicament into the skin of the patient; wherein at leastone of the fluid channels is in fluid communication with the deliverycannula.
 2. The device according to claim 1, wherein: the components inthe first internal region include one or more of a pump, a force sensingresistor, and electronics; and the components in the second internalregion include the delivery cannula.
 3. The device according to claim 1,wherein a size of the fluid channel does not limit fluid flow.
 4. Thedevice according to claim 1, wherein the fluid channel is recessed fromthe bottom surface of the base; and the medicament passes through thebase from the first internal region to the second internal region. 5.The device according to claim 1, wherein the fluid channel is in fluidcommunication with the delivery cannula while bypassing the barrier. 6.The device according to claim 1, further comprising: a plate includingone or more fluid channels; and the fluid channel of the plate beingencapsulated by a fluid channel cover.
 7. The device according to claim6, wherein the fluid channels in the plate are disposed at differentelevations with respect to the base.
 8. The device according to claim 6,wherein the plate is disposed entirely in the first internal region. 9.The device according to claim 1, further comprising a fluid channelcover that encapsulates at least one of the fluid channels.
 10. Thedevice according to claim 9, wherein the cover comprises foil attachedto the base.
 11. The device according to claim 9, wherein the coverseals the bottom surface of the base.
 12. The device according to claim9, wherein the cover encapsulates each of the fluid channels.
 13. Thedevice according to claim 9, wherein a separate cover encapsulates eachof the fluid channels.
 14. The device according to claim 1, wherein: oneof the fluid channels transfers medicament to an input of a component ofthe device component; and one of the fluid channels transfers medicamentfrom an outlet of the component of the device component to the deliverycannula.
 15. The device according to claim 14, wherein the component ofthe device component comprises a force sensing resistor.
 16. Amedicament delivery device comprising: a housing having an interior, thehousing having a fluid channel disposed therein; wherein the fluidchannel passes from a first position in the interior, to a secondposition outside the housing, and to a third position in the interior.17. The medicament delivery device according to claim 16, wherein thefluid channel is recessed into the housing.
 18. A medicament deliverymethod comprising: disposing medicament in an interior of a housing; andtransporting the medicament in a fluid channel traveling from theinterior of the housing to outside of the housing, and back into theinterior of the housing.
 19. The method according to claim 18, whereinthe fluid channel is recessed into the housing.
 20. A medicamentdelivery device comprising: a housing having an interior, the housingincluding: a reservoir for housing medicament; a fill port in fluidcommunication with the reservoir; a delivery mechanism that delivers themedicament into skin of a patient; a pump that controls flow of themedicament to the delivery mechanism; and a base having first and secondfluid channels disposed therein; wherein the pump is in fluidcommunication with the delivery mechanism via the first fluid channel;and one of the fluid channels is disposed, at least in part, outside theinterior of the housing.
 21. The medicament delivery device according toclaim 20, wherein the fill port is in fluid communication with the pumpvia the second fluid channel.